Study: Women underrepresented in clinical trials of medical devices

Women are underrepresented in clinical trials of medical devices and are significantly underrepresented in clinical trials evaluating cardiovascular devices compared with devices in other specialties, according to a systematic review published in JAMA Internal Medicine.

While women’s representation in drug trials has improved, the authors said, their representation in medical device trials has not. In 2014, the US Food and Drug Administration (FDA) published a final guidance document outlining sex-specific considerations for medical device clinical studies, including recommendations to more accurately reflect the intended population of the device. The Center for Devices and Radiological Health (CDRH) also made representation of women in clinical trials of medical devices part of a CDRH Health of Women Program strategic plan in 2022.

The problem of enrolling a representative proportion of women persists in clinical trials of medical devices, according to Nitzan Karny Epstein of the infectious diseases unit at Meir Hospital in Kfar-Saba, Israel, and colleagues.

“Our review highlights underrepresentation of women in device trials across medical fields,” they wrote. “Improved awareness and initiatives are essential to ensure adequate enrollment, considering potential gender-specific differences in medical device performance.”

Epstein and colleagues performed a systematic review of 195 trials between 2013 and 2022 that evaluated medical devices in the areas of cardiology, orthopedics, and other specialties, including neurology, endocrinology, gastroenterology, pulmonary, and ear, nose, and throat. Overall, most of the clinical trials evaluated cardiovascular (128 trials) and orthopedic (37 trials) medical devices. The most common types of medical devices evaluated included stents (73 trials), prostheses (34 trials), valves (30 trials), pumps (14 trials), pacemakers (13 trials), and other devices (25 trials). The researchers calculated the participation-to-prevalence ratio (PPR) for devices by dividing the percentage of women in clinical trials for a particular device type by the prevalence of that device type used by women in the general population.

The results showed trials of cardiovascular devices had a median 29% of women represented in clinical trials. In comparison, orthopedic devices had a median 46% representation, and other devices had a median 47% representation of women. When comparing devices, the PPR for the representation of women in clinical trials was 0.77 for stents (0.66-0.94), 0.76 for valves (95% CI, 0.67-0.88), 0.69 for prostheses (95% CI, 0.52-1.19), 0.56 for pumps (95% CI, 0.49-1.19), and 1.00 for pacemakers (95% CI, 0.77-1.47). The researchers noted no significant differences in participation of women by date of publication or by date of trial start.

“The most limiting step for women’s recruitment is the screening stage; higher awareness of physicians may improve enrollment,” the authors wrote. They also noted that more women are recruited in trials led by women and that “stakeholders should consider implementing gender equity criteria for researchers involved.”

Addressing barriers to the recruitment of women
In a related editorial, Jessica N. Holtzman and Rita F. Redberg of the department of medicine at the University of California, San Francisco, said the problem of women being underrepresented in clinical trials is an issue the FDA has tried to address for decades and includes “more than 30 years of FDA workshops and guidance to encourage enrollment of women.”

“Barriers to the enrollment of women include exclusion criteria that inadvertently or directly exclude women (e.g., upper age cutoffs, pregnancy or breastfeeding), family responsibilities that may limit the time women can devote to participation in trials, and the lack of women who are principal investigators in cardiovascular device trials,” they said.

Holtzman and Redberg proposed potential improvements to aid in the recruitment of women in clinical trials, including the use of sex-specific diagnostics and measurements, changing the inclusion criteria to make it easier for working women to participate, and improving the quality and consistency of sex- and gender-based clinical data collection and reporting. They also called on FDA to decline review of clinical trial data that do not reflect the population of the device or drug’s intended users.

“A growing number of investigators, patient advocacy groups, and professional societies are paying attention to gender equity in clinical trial enrollment,” they said. “At present, we are poised to translate our knowledge of the underrepresentation of women in clinical trials into action and require adequate enrollment. Then the FDA can fulfill its mission of assuring the safety and effectiveness of drugs and devices for every person.”

JAMA Intern Med Epstein et al
JAMA Intern Med Holtzman et al

Study: Women underrepresented in clinical trials of medical devices

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